Kamila Novak

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Contributor at Clinical Leader

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Articles

If Sponsors Invite Patients To See The Final Draft Protocol, It's Already Too Late

Sep 16, 2024 | clinicalleader.com | Kamila Novak

By Kamila Novak, KAN Consulting In any project, we want to achieve and should plan for success, which requires considering internal and external stakeholders and product end users. It is not any different in drug development. Sponsors wish to launch a successful product, win a good market share, and gain revenue. Meeting the needs of the target patient population is vital to those ends. This implies knowing the patients and their needs very well. Who are they? How old are they?
07.08.24 -- New Law Expected To Boost Clinical Research In Brazil

Jul 8, 2024 | clinicalleader.com | Paulo Fernandes |Alain Michon |Kamila Novak

Patient recruitment and retention is a multi-faceted, critical component of clinical trial success. Diversity, timeliness, enrollment, reimbursement, logistics, engagement – where do you start? On August 7th, hear from industry-leading suppliers ready to answer that question – and help solve your specific recruitment and retention challenges. The Clinical Leader Solutions Expo brings you its latest virtual event to help facilitate partnerships that bring life-saving therapies to patients.
07.01.24 -- Effective Feasibility Strategies For Research-Naïve Sites

Jul 1, 2024 | clinicalleader.com | Dan Schell |Christine Guo |Kamila Novak

Webinar: Building One Home for Sites – The only industry-wide solution to site tech overloadPharmaceutical companies have asked clinical research sites to use more and more technology to execute the trials they sponsor leading to site tech overload. Join us in this webinar to discover what can be done to take away the burden on sites and still gain the benefits being delivered by clinical technology innovators. Click here to learn more.
Going Beyond Generative AI And Templates To Create Informed Consent Documents

Jun 17, 2024 | clinicalleader.com | Kamila Novak

By Kamila Novak, KAN Consulting A voluntarily signed informed consent document (ICD) became the prerequisite for study participation in 1948 after the Nuremberg trials and is regarded as one of the pillars of research ethics acknowledging the autonomy of individuals. We all know that ICDs should be easy to understand and written in plain language with terms explained. Nevertheless, today’s ICDs are excessively lengthy, complex, and difficult to read.
2 Ways To Make Eligibility Checklists More Meaningful

Jun 9, 2024 | clinicalleader.com | Kamila Novak

By Kamila Novak, KAN Consulting An eligibility assessment of screened participants is one of the three key activities — the other two being safety evaluations and adherence to the allocated therapy — that ensure the data collected and analyzed can be used for sponsors’ and regulatory decision-making.
02.08.24 -- Competence And Qualifications In The GCP World

Feb 8, 2024 | clinicalleader.com | Kamila Novak |Thomas Wicks |Rachana MSc

Is Being Competent And Qualified The Same Thing In The GCP World? When it comes to good clinical practice principles, the mention of "competence" is underwhelming. Yet, there is plenty of talk about education, training, and experience. Are "competent" and "qualified" synonymous? Does one imply the other? And why does it matter? Kamila Novak of KAN Consulting explores.
New Calculator Could Help Trial Participants And Sponsors Determine Costs And Fair Compensation

Dec 14, 2023 | clinicalleader.com | Kamila Novak |Larry Ajuwon

By Larry Ajuwon, director at Rhieos-Ventures and lead partner at TrialValue Clinical trials come with benefits, risks, and costs that influence a patient’s decision to participate and affect their conduct during and after the trial. Financial, in addition to logistical, burdens have been shown to affect recruitment, access to study sites, and completion rate1.
12.01.23 -- Do We Need An IRB/IEC Revolution?

Nov 30, 2023 | clinicalleader.com | Kamila Novak

Join The Clinical Tech Leader CommunityWe’re excited to introduce a new online community focused on all aspects of clinical trial technologies! Clinical Tech Leader will help you identify, evaluate, and implement technology solutions for your biggest clinical trial challenges. Sign up for the free Clinical Tech Leader newsletter, delivered to your inbox weekly. Do We Need An IRB/IEC Revolution? Are IRBs and IECs the same? If not, how are they different?
Do We Need An IRB/IEC Revolution?

Nov 9, 2023 | clinicalleader.com | Kamila Novak

By Kamila Novak, KAN Consulting Let’s start with the basics and look at the definitions of Institutional Review Board (IRB) and Independent Ethics Committee (IEC). In the current Good Clinical Practice guideline, ICH E6 (R2)1, we find two definitions — although industry has been using the terms interchangeably, seeing both bodies as one and the same thing. As we can see, the GCP definitions are very much alike. What Is An IRB/IEC?
07.24.23 -- Study Participant Consenting: Can We Do A Better Job?

Jul 23, 2023 | clinicalleader.com | Kamila Novak

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